Intas Pharmaceuticals Ltd. is inviting applications for the position of Regulatory Affairs Specialist / Senior Executive (ANZ – Injectables) at its Corporate Head Office in Ahmedabad, Gujarat.
Candidates with B.Pharm, M.Pharm, or a relevant Life Sciences qualification and 3–5 years of experience are eligible to apply.
The role focuses on regulatory affairs for injectable products, including dossier preparation, regulatory submissions, variations, renewals, and artwork management.
Professionals with experience in Australia’s TGA regulatory requirements, New Zealand markets, and CTD/eCTD documentation can apply for this work-from-office opportunity.
Intas Pharmaceuticals Regulatory Affairs Recruitment
Intas Pharmaceuticals Ltd. is expanding its Regulatory Affairs team for the ANZ (Australia and New Zealand) Injectables business. The company is seeking experienced professionals with knowledge of pharmaceutical regulatory compliance, injectable product documentation, and international regulatory requirements.
This opportunity is based at the company’s Corporate Head Office in Ahmedabad, Gujarat, and is suitable for candidates with relevant regulatory affairs experience.
Company Overview
Intas Pharmaceuticals Ltd. is a pharmaceutical company with global operations. Its Regulatory Affairs department supports regulatory compliance, product registrations, and submissions across international markets.
Job Role & Responsibilities
Regulatory Affairs Specialist / Senior Executive (ANZ – Injectables)
The selected candidate will support regulatory activities related to injectable pharmaceutical products for Australia and New Zealand markets.
Key responsibilities and areas of expertise include:
- Preparing and compiling regulatory dossiers for injectable products.
- Managing regulatory submissions, variations, and renewals.
- Responding to regulatory queries and supporting approval-related activities.
- Working with CTD and eCTD documentation.
- Supporting pharmaceutical regulatory compliance and artwork management.
- Applying knowledge of international regulatory guidelines.
- Coordinating regulatory documentation for Australia and New Zealand markets.
Eligibility & Qualifications
Educational Qualification
Candidates with the following qualifications may apply:
- B.Pharm
- M.Pharm
- Relevant Life Sciences qualifications
Experience Required
- Experience: 3–5 years, as applicable to the position.
- Hands-on experience working with injectable pharmaceutical products.
- Experience in regulatory affairs and pharmaceutical regulatory compliance.
- Exposure to semi-regulated markets, particularly Australia and New Zealand.
Required Technical Skills
- Knowledge of Australia’s Therapeutic Goods Administration (TGA) requirements.
- Experience in regulatory dossier compilation and submissions.
- Understanding of variations, renewals, and regulatory query responses.
- Knowledge of CTD/eCTD formats and international regulatory guidelines.
- Experience with pharmaceutical artwork management.
Location & Work Mode
- Location: Intas Pharmaceuticals Ltd., Corporate Head Office, Ahmedabad, Gujarat.
- Work Mode: Work from office.
- Department: Regulatory Affairs.
- Business Area: ANZ – Injectables.
Salary Details
The salary has not been specified in the recruitment announcement. Compensation may depend on the candidate’s experience, qualifications, and the company’s internal salary structure.
How to Apply
Interested and eligible candidates can share their updated resume directly with the recruitment contact.
- Email: sdwivedi@intaspharma.com
- Email Subject: Opportunity for INTAS- IRA – ANZ (Inj. Dosses form)
Candidates should include their relevant regulatory affairs experience, injectable product expertise, and Australia/New Zealand market exposure in their resumes.
Applicants may also contact the recruitment team through the professional networking channel where the vacancy was shared.
Important Recruitment Notice
Intas Pharmaceuticals does not charge candidates any fee for job applications, processing, training, testing, or any other stage of recruitment.
Candidates should avoid recruitment invitations requesting payment or monetary consideration.
Frequently Asked Questions
1. Which company is hiring for the Regulatory Affairs position?
Intas Pharmaceuticals Ltd. is recruiting for its Regulatory Affairs department.
2. What positions are available?
The openings are for Regulatory Affairs Specialist / Senior Executive in the ANZ – Injectables team.
3. What qualifications are required?
Candidates with B.Pharm, M.Pharm, or a relevant Life Sciences qualification may apply.
4. How much experience is required?
The recruitment announcement specifies 3–5 years of experience, as applicable to the position.
5. Is experience with injectable products required?
Yes. Hands-on experience with injectable products is listed as a key requirement.
6. How can candidates apply?
Candidates can send their updated resumes to sdwivedi@intaspharma.com with the specified subject line.
Job Summary
| Category | Details |
|---|---|
| Company | Intas Pharmaceuticals Ltd. |
| Vacancies | Regulatory Affairs Specialist / Senior Executive (ANZ – Injectables) |
| Required Education | B.Pharm / M.Pharm / Relevant Life Sciences qualification |
| Experience | 3–5 years, as applicable |